Quality Assurance Associate (Raleigh)

Job Summary :

The Quality Assurance Associate will ensure that all manufacturing activities, documentation, and products comply with cGMP, regulatory, and company quality standards. This role supports batch record review, deviation management, and quality oversight of production operations to maintain product integrity and compliance throughout the manufacturing process. The ideal candidate has strong attention to detail, solid understanding of QA principles, and experience within a pharmaceutical or biologics manufacturing environment.

Responsibilities :

• Review and approve batch records, deviations, change controls, and CAPAs.
• Provide on-the-floor quality support during manufacturing operations to ensure cGMP compliance.
• Participate in internal audits, inspections, and continuous improvement initiatives.
• Support quality system processes including document control, training, and validation.
• Collaborate with cross-functional teams to resolve quality issues and ensure timely product release.
• Maintain accurate and compliant quality documentation and records.

Qualifications :

• Bachelors degree in Life Sciences, Engineering, or related field.
• Minimum 3 years of experience in a pharmaceutical or biologics manufacturing environment, preferably in Quality Assurance.
• Strong knowledge of cGMP, FDA, and ICH regulations.